CHINA_GEL (Camphor 3.00%, Menthol 5.00%) A TOPICAL PAIN RELIEVER, packaged as a) 2 OZ (56.8g) tube, NDC 76305-300-13;
Summary
The FDA issued a Class II for CHINA_GEL (Camphor 3.00%, Menthol 5.00%) A TOPICAL PAIN RELIEVER, packaged as a by China Gel Inc. Reason: CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products..
Details
Source
Drug Recall
External ID
D-0788-2021
Action Date
2021-09-08
Status
Ongoing
Category
drug
Product Description
CHINA_GEL (Camphor 3.00%, Menthol 5.00%) A TOPICAL PAIN RELIEVER, packaged as a) 2 OZ (56.8g) tube, NDC 76305-300-13; b) 4 OZ (113.5g) jar, UPC 6 87806 10004 2, NDC 76305-300-02; c) 6 OZ (170 g) tube, UPC 6 87806 10006 2, NDC 76305-300-03; d) 8 OZ (226.8g) jar, UPC 6 87806 10008 2, NDC 76305-300-04; e) 16 OZ (453.6g), Bottle w/ Pump, UPC 6 87806 10016 7, NDC 76305-300-03; f) 128 OZ (3.78L) Gallon, UPC 6 87806 10128 7, NDC 76305-300-06; Distributed by: CHINA-GEL LLC, Arlington Heights, IL 60005,
Lot/Code Info: Lot #: a)B122DY, exp 2021-05; B183GN, exp 2021-07; B262BF, exp 2021-09; C002KF, exp 2022-01; C030HT, exp 2022-02; C094LT, exp 2022-04; C275CW, exp 2022-10; C338CH, exp 2022-12; b) B122DX, exp 2021-05; B183GP, exp 2021-07; B262BE, exp 2021-09; C002KF, exp 2022-01; C030HT, exp 2022-02; C094LT, exp 2022-04; C275CW, exp 2022-10; C330BG, exp 2022-12 c) B122DY, exp 2021-05; B183GN, exp 2021-07; B262BF, exp 2021-09; C002KF, exp 2022-01; C030HT, exp 2022-02; C094LT, exp 2022-04;C156FF, exp 2022-06; C247JB, exp 2022-09; C338CH, exp 2022-12. d)B122DX, Exp 05/2021; B122DY , EXP 05-2021; B183GP, EXP 07-2021; B262BE, EXP 09-2021; B262BF, EXP 09-2021; C002KF, EXP 01-2022; C030HT, EXP 02-2022; C094LT, EXP 04-2022; C156FF, EXP 06-2022; C247JB, EXP 09-2022; C275CW, EXP 10-2022; C330BG, EXP 12-2022; e) B100JS, Exp 04/2021; B183GQ, EXP 07-2021; B255KZ, EXP 09-2021; C030HS, EXP 02-2022; C100AH, EXP 04-2022; C247JF, EXP 09-2022; f) B122DY , EXP 05-2021; B183GN, EXP 07-2021; B183GP, EXP 07-2021; B262BF, EXP 01-2022; C002KF, EXP 02-2022; C030HT, EXP 02-2022; C094LT, EXP 04-2022; C156FF, EXP 09-2022; C275CW, EXP 12-2022; C338CH, EXP 05-2022;
Quantity Affected: 92,472 each
Reason for Recall
CGMP deviations: Product being recalled as it was made in the same facility where contamination with B. cepacia was found in other products.
Distribution
Distributed Nationwide in the USA as well as Australia, Canada, France, Germany, Ireland, Norway, Turks & Caicos, Republic of Maldives, Russia, Singapore, Switzerland, United Kingdom
Type: Voluntary: Firm initiated
Recall Initiated: 2021-03-10
Company
Arlington Heights, IL
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 40 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
China Gel Inc has 3 FDA actions in our database, including 3 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (China Gel Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does China Gel Inc have FDA actions?
China Gel Inc has 3 FDA actions in our database, including 3 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0788-2021" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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